BAI takes lead in regulating animal health products

MANILA, Philippines – The Department of Agriculture (DA) has issued guidelines to speed up approvals for animal health products under the Animal Industry Development and Competitiveness Act.

Under Department Circular No. 33, the DA laid out transitional rules for licensing establishments and registering veterinary drugs, biologics and related products. The guidelines also cover the licensing and listing of other animal health products and devices for food, companion, laboratory, aquatic and exotic animals.

Agriculture Assistant Secretary Arnel de Mesa said the order would help speed-up approvals now that a dedicated agency oversees animal health products.

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Before the law took effect last year, the Food and Drug Administration (FDA) regulated all drugs and products, including veterinary medicines.

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“Now, since there is a specific agency focused on animal products and animal biologics, the approval process is faster,” said de Mesa, who also serves as the DA spokesperson, during a press briefing on Wednesday.

“Also, the expertise of the veterinarians in the laboratory at the Bureau of Animal Industry, we can expect faster processing within the (BAI),” he told reporters.

Under the law, the Bureau of Animal Industry (BAI) grown its mandate and became a line agency attached to the DA, making it the sole regulator of veterinary drugs, biologics and other animal health products.

BAI’s expanded role

Meanwhile, the order requires veterinary establishments to secure a license to operate (LTO) from the BAI before manufacturing, trading, importing, exporting, distributing or selling veterinary drugs, biologics and related animal health products and devices.

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“Only establishments with adequate facilities, qualified personnel, and systems ensuring the safety, efficacy, and quality of veterinary drugs, products, and biologics shall be granted an LTO,” the circular read.

To qualify, establishments must fully disclose details of their business operations to prove their legitimacy and technical capability.

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